Recon: FDA shelves commissioner's voucher program; Eli Lilly gets first GLP-1 weight-loss pill approved in China

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• FDA shelves commissioner's voucher program for speedy drug reviews, sources say (Reuters)
• Merck KGaA lands FDA nod for joint tumor drug it licensed from Abbisko (Endpoints) (Fierce Pharma)
• Cassidy sets key vote on Overton, even as he remains undecided on nominee to lead FDA (STAT) (Endpoints)
• FDA warns Chinese providers of compounding APIs over record-request refusals (BioSpace) (Fierce Pharma)
• Former FDA head accuses Trump aides of bowing to industry (Politico)
• BioNTech pays $205M for FDA voucher to speed up ‘late-stage oncology pipeline’ (Fierce Pharma)
• FDA seeking ideas to avoid data use problems when RWE included in application reviews (Pink Sheet)
• The FDA has over 1k open jobs — and the staffing shortage is hitting pharma (PharmaVoice)
• FDA reorg will help address ‘surge’ in cell, gene therapy facility inspections (Pink Sheet)
• US faces loss of measles-free status as experts meet for review (Reuters)

In Focus: International

• Eli Lilly becomes first drugmaker to have a GLP-1 weight-loss pill approved in China (Reuters)
• Aspen Pharmacare wins approval for generic semaglutide in Brazil, South Africa (Reuters)
• Incyte gains MHRA license and NICE approval of Zynyz in anal cancer (The Pharma Letter)
• ‘I want your money’: UK science minister calls for more life sciences investment (Endpoints)
• Drug price hikes in Germany could push US costs higher, study says (BioPharma Dive) (The Pharma Letter)
• Korea regulator plans new up to six-fold fee hikes to meet costs (Pink Sheet)
• Fast approval, delayed start? EU speeds modifications to clear trial-blocking conditions (Pink Sheet)
• India’s push for more reliable drug manufacturing (The Pharma Letter)
• Why the EU JCA report for AstraZeneca’s Etcamah took more than 100 days (Pink Sheet)

Pharma & Biotech

• Bristol Myers to merge R&D under Massacesi, research head to exit (Endpoints) (Reuters)
• Blackstone commits up to $1.5B for R&D of Pfizer's ex-Metsera GLP-1 (Endpoints) (Reuters)
• Radiopharma player PharmaLogic snaps up Lantheus' CDMO business, plant as Curium acquisition advances (Fierce Pharma)
• Amgen's Sjogren's drug cuts disease activity in trial (Reuters) (The Pharma Letter)
• Beeline reveals phase 2 lupus data from old Bristol Myers drug (Endpoints) (The Pharma Letter)
• All of Us study finds thousands of new genetic variants affecting drug responses (STAT)
• Takeda launches sleep disorder pill in the US after DEA clearance removes final hurdle (Reuters)
• Lilly enters deal with Gedeon Richter for E4 platform (The Pharma Letter)
• Mirum plans FDA submission for hepatitis D treatment as competition brews (Endpoints)
• Capricor ramps up manufacturing spend ahead of FDA decision for DMD therapy (BioSpace)

Medtech

• Abbott’s defibrillation lead lands FDA approval and CE mark (Medtech Dive)
• Oura to acquire Counsel Health for $625 million, placing a big bet on AI care (STAT) (Endpoints)
• Tandem recalls Mobi insulin pump, reports 230 adverse events (MedTech Dive)
• The material difference: FDA warning letters reinforce 510(k) expectations for material changes (FDA Law Blog)
• CMS revises remote monitoring payments, sets Medicare rates for 14 software-based diagnostic tools (Medtech Insight)
• EU provides more breakthrough device details as pilot enters next phase (Medtech Insight)
• ‘Warning shot’: Medtech’s IT breaches could hand hackers a blueprint for device attacks (Medtech Insight)
• German medtechs count on government’s strategic input amid uptick in mood of industry (Medtech Insight)
• Olympus lifts full-year revenue floor as FDA import alerts weigh on surgical shipments (Medtech Insight)
• Impact of Theranos still haunts diagnostics companies, say leaders at Babson and Truvian (Medtech Insight)

Food & Nutrition

• The problems with America's bottomless shrimp appetite (Bloomberg)
• Europe on alert as cyberattacks lead to spoiled food (Food Safety News)

Government & Legal

• Doctors on Kennedy’s influential preventive care panel have major conflicts of interest, filings reveal (STAT)
• Democrats ramp up oversight of MFN deals after midterm wins (STAT)
• DOJ’s FCA self-disclosure pilot not a one-and-done remedy (Medtech Insight)
• Three things new governors must do to lead on health (STAT)
• I research MAHA and Black Americans. The relationship is complicated — and fascinating (STAT)
• RFK Jr. unleashed? New chief of staff infuses HHS secretary with confidence despite midterm losses (Endpoints)
• Medicare obesity drug coverage unlikely to lapse after 2027, Lilly’s Ricks says (Pink Sheet)
• Five US states join FTC suit against Hims & Hers over privacy practices (Reuters)
• Hospitals brace for Medicaid work rules and deep funding cuts (New York Times)

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.